Data collection device

ABSTRACT

A data collection device for attachment to an injection device and for collecting medicament dosage information therefrom.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of the U.S. Pat. ApplicationNo. 16/652,449, filed Mar. 31, 2020, the national stage entry ofInternational Patent Application No. PCT/EP2018/076731, filed on Oct. 2,2018, and claims priority to Application No. EP 17306568.1, filed onNov. 13, 2017, and Patent Application No. 62/569,357, filed on Oct. 6,2017, the disclosures of which are incorporated herein by reference.

TECHNICAL FIELD

The present disclosure relates to a data collection device forattachment to an injection device and for collecting medicament dosageinformation therefrom.

BACKGROUND

A variety of diseases exists that require regular treatment by injectionof a medicament. Such injection can be performed by using injectiondevices, which are applied either by medical personnel or by patientsthemselves. As an example, type-1 and type-2 diabetes can be treated bypatients themselves by injection of insulin doses, for example once orseveral times per day. For instance, a pre-filled disposable insulin pencan be used as an injection device. Alternatively, a re-usable pen maybe used. A re-usable pen allows replacement of an empty medicamentcartridge by a new one. Either pen may come with a set of one-wayneedles that are replaced before each use. The insulin dose to beinjected can then for instance be manually selected at the insulin penby turning a dose setting dial and observing the actual dose from a dosewindow or display of the insulin pen. The dose is then injected byinserting the needle into a suited skin portion and pressing the dosesetting dial or an injection button of the insulin pen. To be able tomonitor insulin injection, for instance to prevent false handling of theinsulin pen or to keep track of the doses already applied, it isdesirable to measure information related to a condition and/or use ofthe injection device, such as for instance information on the injectedinsulin dose.

SUMMARY

In one aspect, a data collection device for releasable attachment to arotatable dose setting dial of a medicament administration deviceincludes a cavity configured to receive the dose setting dial, acoupling member disposed within the cavity on an inner surface of thedata collection device and configured to releasably couple the datacollection device to the dose setting dial, and an orientation elementdisposed within the cavity on the inner surface of the data collectiondevice and configured to engage with an indentation disposed on the dosesetting dial.

In some embodiments, the data collection device includes a first end, asecond end opposing the first end, and a wall extending between aportion of a periphery of the first end and a portion of a periphery ofthe second end. The first end, the second end and the wall togetherdefine the cavity. The second end includes a notch configured to receivea dial sleeve of the medicament delivery device, and the wall includes aslot configured to permit insertion of the dose setting dial of themedicament delivery device through the slot and into the cavity.

In some embodiments, the coupling member is disposed within the cavityon an inner surface of the first end.

In some embodiments, the orientation element is disposed on an innersurface of the wall of the data collection device.

In some embodiments, the coupling member is configured to couple thedata collection device to the dose setting dial when the dose settingdial is received in the cavity of the data collection device.

In some embodiments, the coupling member includes a resilientlydeformable member.

In some embodiments, the orientation element is a protrusion extendingfrom the inner surface of the data collection device.

In some embodiments, rotation of the data collection device relative tothe dose setting dial is prevented when the orientation element of thedata collection device is engaged with the indentation on the dosesetting dial.

In some embodiments, when attached to the dose setting dial of themedicament administration device, rotation of the data collection devicecauses rotation of the dose setting dial.

In some embodiments, the device has a generally cylindrical shape.

In some embodiments, the data collection device further includes a lightsource configured to illuminate a portion of a surface of a component ofthe medicament administration device including one or more relativelyreflective regions formed on the surface of the component and an opticalsensor configured to receive light reflected by at least the relativelyreflective regions.

In some embodiments, the data collection device further includes awindow configured to allow light emitted by the light source to passthrough it.

In some embodiments, the data collection device has a longitudinal axisand is configured to be mounted onto the dose setting dial by (i)orienting the data collection device such that the longitudinal axis isparallel to an axis of rotation of the dose setting dial and such thatthe orientation element is aligned with the indentation on the dosesetting dial and (ii) moving the data collection device in aperpendicular direction with respect to the axis of rotation of the dosesetting dial.

In another aspect, a dose setting dial is configured to be releasablycoupled to one of the data collection devices described above.

In some embodiments, the dose setting dial includes a channel configuredto releasably couple with the coupling member of the data collectiondevice and an indentation configured to engage with the orientationelement of the data collection device.

In some embodiments, the dose setting dial further includes a window.

In a further aspect, a system includes a medicament administrationdevice including a housing, a rotatable dose setting dial, a dial sleeveat least partially located within the housing and including one or morerelatively reflective regions formed on the surface of the dial sleeve,and one of the data collection devices described above. The dial sleeveand dose setting dial are rotationally coupled during dose setting anddose resetting of the device and rotationally decoupled during dosedispensing of the device.

In an additional aspect, a system includes one of the dose setting dialsdescribed above and one of the data collection devices described above.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 shows an exploded view of an injection device for use with a datacollection device.

FIG. 2 depicts a data collection device, attached to the injectiondevice of FIG. 1 .

FIG. 3 a shows a cross-sectional view of a dose setting dial of theinjection device.

FIG. 3 b shows a perspective view of the dose setting dial of FIG. 3 a .

FIG. 4 depicts a cross-sectional view of the data collection device.

FIG. 5 shows a cross-sectional view of the data collection device.

FIG. 6 shows a cross-sectional view of the data collection device,attached to the injection device of FIG. 1 .

FIG. 7 is a block diagram of the data collection device.

FIG. 8 shows a system in which the data collection device is connectedto another device, such as a personal computer.

DETAILED DESCRIPTION

In the following disclosure, embodiments will be described withreference to an insulin injection device. The present disclosure ishowever not limited to such application and may equally well be deployedwith injection devices that eject other medicaments.

FIG. 1 is an exploded view of a medicament administration device. Inthis example, the medicament administration device is an injectiondevice 1, such as Sanofi’s AllStar® insulin injection pen, however thepresent invention is also compatible with other types and makes ofinjection pens as described below.

The injection device 1 of FIG. 1 is a pre-filled injection pen thatcomprises a housing 2 and contains an insulin container 3, to which aneedle 4 can be affixed. The injection device 1 may be disposable orre-usable. The needle is protected by an inner needle cap 5 and eitheran outer needle cap 6 or an alternative cap 7. An insulin dose to beejected from injection device 1 can be programmed, or ‘dialled in’ byturning a dose setting dial 8 and a currently programmed dose is thendisplayed via dosage window 9, for instance in multiples of units. Forexample, where the injection device 1 is configured to administer humaninsulin, the dosage may be displayed in so-called International Units(IU), wherein one IU is the biological equivalent of about 45.5micrograms of pure crystalline insulin (1/22 mg). Other units may beemployed in injection devices for delivering analogue insulin or othermedicaments. It should be noted that the selected dose may equally wellbe displayed differently than as shown in the dosage window 9 in FIG. 1.

The medicament delivery device 1 has distal and proximal ends. The term“distal” refers to a location that is relatively close to the site ofinjection, and the term “proximal” refers to a location that isrelatively further away from the injection site. In the presentembodiment, the needle 4 is situated towards the distal end of thedevice 1, whilst the dose setting dial 8 is situated towards theproximal end of the device 1. The device 1 has a longitudinal axis whichextends between the proximal and distal ends of the device 1.

The dosage window 9 may be in the form of an aperture in the housing 2,which permits a user to view a limited portion of a number sleeve 10that is configured to move when the dose setting dial 8 is turned, toprovide a visual indication of a currently programmed dose. The numbersleeve 10 may be a component which rotates when a dose is beingdispensed from the injection device 1.

In this example, the dose setting dial 8 includes one or more formations11 a, 11 b that facilitate programming because they improve the grip auser feels when grasping the dose setting dial 12. In another example(not shown) the dose setting dial does not include formations. Attachinga data collection device does not require the dose setting dial havingformations.

The dose setting dial 8 comprises an indent or groove 12 which isconfigured to engage with a protruding orientation element positioned ona data collection device. When the groove 12 is engaged with theorientation element of the data collection device, the data collectiondevice is in a pre-defined position. The orientation element helps toalign the data collection device in a pre-defined position by aligningthe groove 12 of the dose setting dial with the orientation element ofthe data collection device.

The stability of the connection between the data collection device andthe dose setting dial may be increased. For example, having a tight fitand/or using rubber-like material at the contact surface between thedata collection device and the injection device would provide anattachment that, on the one hand, facilitates a stable connection in thesense that the two devices remain attached to each other and, on theother hand, allows the two devices to be separated when desired. Therubber-like material would ensure a proper fit even on a smooth surface,e. g, a dose setting dial having a smooth surface such that thatrotation of the data collection device causes rotation of the dosesetting dial and vice versa.

The dose setting dial 8 further comprises a window 13 which isconfigured to allow the passage of light through the dose setting dial 8and onto an internal component of the medicament delivery device 1. Thewindow 13 is further configured to allow light reflected by an internalcomponent of the medicament delivery device 1 to pass through and thewindow 13 and out of the device.

The dose setting dial 8 is configured to be rotated to set a dose. Thiscauses the dose setting dial 8 to move proximally away from the housing2. When a dose is dispensed from the injection device 1, the dosesetting dial 8 moves back (distally) towards the housing 2 but does notrotate. Rotation of the dose setting dial 8 also causes the dial sleeve10 to move proximally out of the housing 2. When a dose is dispensedfrom the injection device 1, the dial sleeve 10 rotates and moves back(distally) into the housing 2, but the dose setting dial 8 does notrotate.

The injection device 1 may be configured so that turning the dosesetting dial 8 causes a mechanical click sound to provide acousticalfeedback to a user. The number sleeve 10 mechanically interacts with apiston in insulin container 3. When needle 4 is stuck into a skinportion of a patient, a user depresses the entire dose setting dial 8,which moves longitudinally relative to the housing 2, in order to causethe medicament to be dispensed. During this dispensing operation, theinsulin dose displayed in display window 9 will be ejected frominjection device 1. When the needle 4 of injection device 1 remains fora certain time in the skin portion after the dose setting dial 8 hasbeen depressed, a high percentage of the dose is actually injected intothe patient’s body. Ejection of the insulin dose may also cause amechanical click sound, which is however different from the soundsproduced when using dose setting dial 8.

In the various embodiments, during delivery of the insulin dose, thedose setting dial 8 is returned to its initial position in an axialmovement, that is to say without rotation, while the number sleeve 10 isrotated to return to its initial position, e.g. to display a dose ofzero units.

Injection device 1 may be used for several injection processes untileither the insulin container 3 is empty or the expiration date of themedicament in the injection device 1 (e.g. 28 days after the first use)is reached.

Furthermore, before using injection device 1 for the first time, it maybe necessary to perform a so-called “prime shot” to remove air frominsulin container 3 and needle 4, for instance by selecting two units ofinsulin and pressing depressing the dose setting dial 8 while holdinginjection device 1 with the needle 4 upwards. For simplicity ofpresentation, in the following, it will be assumed that the ejectedamounts substantially correspond to the injected doses, so that, forinstance the amount of medicament ejected from the injection device 1 isequal to the dose received by the user. Nevertheless, differences (e.g.losses) between the ejected amounts and the injected doses may need tobe taken into account.

FIG. 2 is a perspective view of one end of the injection device 1 when adata collection device 14 according to an example embodiment isattached. The data collection device 14 includes a housing 15 with anend plate 16 forming a user interaction surface. The housing 15 maysupport an optical user feedback such as one or more LEDs (not shown).In some optional embodiments, the data collection device 14 comprises adisplay (not shown)

The data collection device 14 is compatible with a number of existinginjection devices 1 which have an integrated dial. The data collectiondevice 14 is compatible with injection devices where the dose settingdial does not rotate during dose administration, but where an internalcomponent close to the dose setting dial does rotate during doseadministration. The data collection device 14 allows the rotation ofthis internal component to be detected and measured.

FIG. 3 a is a top-down view of the dose setting dial 8 whilst FIG. 3 bis a perspective view of the dose setting dial 8. The dose setting dial8 is has a generally circular cross section and comprises groove 12 anda channel 18. As previously explained, groove 12 is configured to engagewith an orientation element of a data collection device. The groove maybe a depression or a indentation which extends partially into the bodyof the dose setting dial 8. Channel 18 is configured to engage with acoupling member of the data collection device. The channel 18 is shapedsuch that it can receive a protrusion that is disposed on the datacollection device. The shape of the channel 18 and the shape of theprotrusion of the data collection device may complement each other.

FIG. 4 is a perspective view of the data collection device 14 accordingto some embodiments. The housing 15 comprises a first end 19, a secondend 20 which is opposite the first end 19 and a wall 21 which extendsfrom at least a portion of the periphery of the first end 19 to at leasta portion of the periphery of the second end 20. The first end 19,second end 20 and wall 21 together define a cavity 35 which isconfigured to receive the dose setting dial 8 of the medicament deliverydevice 1. Other components, such as an electronics assembly, may becontained within the housing.

The first end 19 may be a plate, such as a disc. Further components ofthe data collection device 14 may be contained within the housing 15 orbe disposed on a surface of the housing 15. For example, a couplingmember 22 may be disposed on the inner surface of the first end 19.Alternatively, the coupling member may be disposed on an inner surfaceof the wall 21 or the second end 20. Other components, such as anelectronics assembly, may be contained within the body of the first end.

The second end 20 comprises a notch 37. The notch 37 may be configuredto receive the dial sleeve 10 of the medicament delivery device 1.

The wall 21 comprises a slot 36 which is configured to permit insertionof the dose setting dial 8 into the cavity 35. The slot 36 hasdimensions sufficient to allow for the dose setting dial to be insertedinto the cavity 35. Alternatively, the slot 36 may deform to allow forthe dose setting dial 8 to be inserted into the cavity 35. For example,the wall may be at least partially made from a deformable or aresiliently deformable material. Other components, such as anelectronics assembly, may be contained within the body of wall 21.

The volume of the cavity 35 may be similar to, or substantially the sameas, the volume of the dose setting dial 8. This will help the dosesetting dial 8 to form a tight fit within the cavity 35 of the housing.

The coupling member 22 is configured to engage with channel 18 of thedose setting dial 8 when the data collection device 1 is mounted on thedose setting dial 8. The coupling member 22 may be a component that isattached to the housing 15, such as a resiliently deformable member(e.g. a spring or a spring-loaded clip). Alternatively, the couplingmember 22 may be a component that is an integral part of the housing 15,such as a protrusion. In such embodiments, the protrusion may be madefrom a resiliently deformable material.

FIG. 5 is a cross-sectional view of the data collection device 14according to some embodiments.

The housing 15 may further comprises an orientation element 23 which isconfigured to engage with groove 12 located on the dose setting dial 8.The orientation element 23 may be a protrusion that projects from theinner surface of the wall 21. When the data collection device 14 ismounted on the dose setting dial 8, the orientation element 23 engageswith the groove 12 of the dose setting dial 8. When the orientationelement 23 is engaged with the groove 12 of the dose setting dial 8, thedata collection device 14 is prevented from rotating relative to thedose setting dial 8, i.e. the dose data collection device 14 and dosesetting dial 8 are rotatably locked.

The housing 15 may further comprise a sensor window 24 which isconfigured to allow light to pass into the data collection device from alight source located within the data collection device 14. The sensorwindow 24 may also be configured to allow light to pass through thesensor window 24 into the housing 15 and be received by an opticalsensor located within the data collection device 14. In the illustratedembodiment, the sensor window 24 is located on an internal surface ofthe wall 21 and covers the light source 29 and optical sensor 30. Inalternative embodiments, the sensor window 24 may be located on otherinternal surfaces of the data collection device, such as on an internalsurface of the first end 19 or on an internal surface of the second end20.

FIG. 6 is a cross-sectional view of the data collection device 14according to some embodiments, when attached to the medicament deliverydevice 1.

When attached to the medicament delivery device 1, the dose setting dialat least partially fills the cavity 35 formed by the first end 19, thesecond end 20 and the wall 21 of the data collection device 14.

The data collection device 14 is configured so as to detect and measurethe rotation of the dial sleeve 10 when attached to the injection device1.

The dial sleeve 10 rotates during dose dispense. The data collectiondevice 14 is configured so as to detect and measure the rotation of thedial sleeve 10 when attached to the injection device 1. The injectiondevice 1 shown in FIG. 6 may also have other components which rotatewhen a dose is dispensed, such as a drive sleeve 31.

The data collection device 14 includes a housing 15 and an electronicsassembly 25 disposed inside the housing 15. The coupling member 22 ofthe data collection device 1 is engaged with the channel 18 of the dosesetting dial 8, whilst the orientation element 23 of the data collectiondevice 14 is engaged with the groove 12 located on the dose setting dial8.

The engagement of the coupling member 22 in the channel 18 helps toprevent the data collection device 14 from being removed from the dosesetting dial 8 and it also provides a rotational lock.

When the dose setting dial 12 rotates during programming of the dosage,the data collection device 14 also rotates. The engagement of theorientation element 23 in the groove 12 helps to prevent the datacollection device 14 from rotating independently of the dose settingdial 8. Additionally, resilient padding, such as a foam rubber pad (notshown), may be provided between the inner surface of the data collectiondevice 14 and the outer surface of the dose setting dial 8 to allow fortolerances in the dimensions of the dose setting dial 8 and the datacollection device 14.

The electronics assembly 25 comprises a PCB 26 and a battery 27, forexample in the form of a coin cell. The PCB 26 may support a number ofcomponents including a processor arrangement 28, a light source 29 andan optical sensor 30. In these embodiments, the light source 29 is aninfrared light source and the optical sensor 30 is an infrared opticalsensor. As shown in FIG. 6 , in some embodiments, the light source 29and optical sensor 30 are supported on the side of the PCB which abutsthe dose setting dial 8.

The light source 29 transmits light through the sensor window 24 of thedata collection device 14. The dose setting dial has a window 13 whichis transparent or substantially transparent to light. Thus, the lightemitted by the light source 29 passes through the dose setting dial 8and illuminates the internal components. In particular the number sleeve10 is a hollow cylinder which extends to the proximal end of the housing2 and is releasably fixed to the dose setting dial 8. The cylindricalsurface of the number sleeve 10 therefore sits underneath the dosedelivery button 8 and is illuminated by the infrared light. The dialsleeve 10 is provided with a pattern of relatively reflective andnon-reflective regions on the cylindrical surface. For example, equallyspaced and equally sized reflective and non-reflective sections may bearranged alternately.

During a dose dispensing operation, the light source 29 illuminates thepart of the number sleeve 10 including the pattern of relativelyreflective and non-reflecting regions; and the optical sensor 30receives the light reflected by at least the relatively reflectiveregions. The output of the optical sensor 30 is relayed to the processor28 which calculates an amount of rotation of the number sleeve 10 duringthe dose dispensing operation. From the amount of rotation, thedelivered dose can be calculated. This may be done by the datacollection device 14 or by another computing device. In general, anycomponent which is located close to the dose setting dial and whichrotates when a dose is dispensed from the injection device 1 may be usedas the internal component having the pattern of relatively reflectiveand non-reflective regions formed on a surface thereof.

The relatively reflective and non-reflective regions are disposed on anouter surface of the number sleeve 10, around the circumference. Such anarrangement may allow the reflective and non-reflective regions to belarger or spaced further apart as more space is available on thissurface of the number sleeve 10.

This embodiment may allow the optical path to be minimized and to remainunchanged when the dose setting dial 8 is moved longitudinally relativeto the dial sleeve 10 during dose dispensing. This adds to increaseddose detection reliability. This embodiment also has a simple mechanicaldesign and construction.

Instead of having a light source and optical sensor, the electronicsassembly may comprise a non-contact magnetic sensor, for example a HallEffect sensor. In this embodiment, the rotatable component 10 comprisesa series of magnetic regions and non-magnetic regions, instead ofrelatively reflective and non-reflective regions, spaced alternatelyaround the circumference of the rotatable component 10. The magneticregions may be permanent magnets, such as regions containing magneticparticles or a magnetic ink. As the magnetic and non-magnetic regionsrotate past the magnetic sensor during dose dispense, the magneticsensor detects a periodic change in the strength and optionallydirection of the magnetic field. This information can then be used todetermine the amount (angle) of rotating of the rotatable component 10.The dose setting dial 8 is transmissive or partially transmissive to themagnetic field generated by the magnetic regions, allowing the magneticsensor to detect rotation of the rotatable component 10 remotely andwithout the need for a cut-out or window in the dose setting dial 8.

When the data collection device 14 and injection device 1 are securedtogether, the electronics assembly 25 is configured to abut the dosesetting dial 8. The data collection device 14 effectively replaces thedose setting dial, as the user interacts directly with the datacollection device 14 in the same way as they would with the dose settingdial to set and deliver a dose of medicament.

The electronics assembly 25 comprises numerous components including aPCB 26, the light source 29, the optical sensor 30, a processorarrangement and a battery 27. In some embodiments, the light source 29is an infrared light source and the optical sensor 30 is an infraredoptical sensor. The window 13 of the dose setting dial is transparent orsubstantially transparent to infrared radiation. Thus the light emittedby the light source 29 passes through the window 13 of the dose settingdial 8 and illuminates the internal components. In particular the numbersleeve 10 is a hollow cylinder which extends to the proximal end of thehousing 2 and moves longitudinally with the dose setting dial 8 when adose is set. The number sleeve 10 may be releasably fixed to the dosesetting dial 8 such that the annular end surface of the dial sleeve 10is sits underneath the dose delivery button 8 and is illuminated by theinfrared light of the light source 29. The number sleeve 10 is providedwith a pattern of relatively reflective and non-reflective regions onthe cylindrical end surface. For example, equally spaced and equallysized reflective and non-reflective sections may be arrangedalternately. Alternatively, the drive sleeve 31 or another internalcomponent may be provided with the pattern of relatively reflective andnon-reflective regions.

During a dose dispensing operation, the light source 29 illuminates aportion of the number sleeve 10 including a portion of the pattern ofrelatively reflective and non-reflecting regions; and the optical sensor30 receives the light reflected by at least the relatively reflectiveregions as they pass underneath. The output of the optical sensor 30 isrelayed to a processor (not shown) which calculates an amount ofrotation of the number sleeve 10 during the dose dispensing operation.From the amount of rotation, the delivered dose can be calculated. Thismay be done by the data collection device or by another computingdevice.

In general it is necessary to know the type of the injection device 1 towhich the data collection device 14 is attached in order to determine adose of medicament which has been dispensed. Therefore, in someembodiments, the data collection device 14 measures only the amount ofrotation of the internal component in degrees. This information is savedin a memory of the data collection device 14 and may be communicated bythe data collection device 14 to an external computing device where itis combined with information about the type of injection device 1 inorder to record the delivered medicament dose.

The fixed construction and design of the embodiment of the datacollection device 14 in FIG. 6 has the advantage of a simple mechanicalconstruction (e.g., by minimizing relative movements) which provides anaccurately defined positioning of optical sensor 30 relative to theinjection device housing and the internal component including thepattern of relatively reflective and non-reflecting regions (e.g., dosedial 8) according to this embodiment.

The medicament delivery device 1 comprises a longitudinal axis whichextends between the proximal and distal ends of the medicament deliverydevice 1. The dose setting dial 8 is positioned towards the proximal endof the medicament delivery device 1 and the number sleeve 10 extendsdistally from the underside of the dose setting dial 8. The axis ofrotation of the dose setting dial 8 and the number sleeve 10 correspondsto the longitudinal axis of the medicament delivery device 1.

To mount the data collection device 14 on the medicament delivery device1 the orientation element 23 and the groove 12 on the dose setting dial8 are aligned. In this position, the slot 36 of the wall 21 and thenotch 37 of the second end 20 are positioned so that they face themedicament delivery device 1. The data collection device 14 is thenmoved towards the medicament delivery device 1 in a direction that isperpendicular to the longitudinal axis of the medicament delivery device1. As the data collection device advances towards the medicamentdelivery device 1, the dial sleeve 10 is received in the notch 37 of thesecond end, whilst the dose setting dial 8 is received in the cavity 35of the data collection device 1. As the dose setting dial is receivedinto the cavity 35, the coupling member 22 of the data collection device1 engages with the channel 18 of the dose setting dial 8, therebycoupling the data collection device 14 to the dose setting dial 8.

When the dose setting dial 8 is fully received in the cavity 35 of thedata collection device 14, the orientation element 23 is in engagementwith the indentation 12 of the dose setting dial 8. The orientationelement 23 prevents the data collection device 14 from being incorrectlymounted on the dose setting dial 8 because in order to fully mount thedata collection device 14 on the dose setting dial 8, the orientationelement 23 must be received into the groove 12. Attempting to mount thedata collection device 14 onto the dose setting dial 8 in an incorrectorientation will be prevented by the orientation element 23. Thus, thedata collection device 14 mounts onto the dose setting dial 8 in apre-defined position.

Mounting the dose setting dial 8 in a predefined position on the dosesetting dial 8 ensure that sensor window 24 of the data collectiondevice 14 is in alignment with the window 13 of the dose setting dial 8.In this orientation, the light source 29 can illuminate the pattern ofrelatively reflective and non-reflective regions disposed on theinternal component (e.g. number sleeve 10) of the medicament deliverydevice 1. The orientation element therefore aids alignment of the datacollection device 14.

The data collection device 14 of the present disclosure attachesdirectly to the dose setting dial of the medicament administrationdevice. Previous data collection devices have attached to the mainhousing of the medicament administration device. This can impede the useof the medicament administration device by a user. Many such devicesattach over a dose indication window in the housing of the medicamentadministration device. This obscures the dose indication window, makingthe user wholly reliant on the data collection device to indicate thedialled dose, which may reduce user confidence in the medicamentadministration device. Some other such devices require an additional cutout or aperture in the housing of the medicament administration devicein order to view or connect with an internal moveable component. Cuttingout a part in the housing of the medicament administration device makesthe ingress of dust and dirt inside the delivery mechanism more likely.It may also present problems relating to the sterility of the medicamentadministration device.

The data collection device of the present disclosure is able to monitorthe amount of medicament dispensed from the medicament administrationdevice remotely, without contacting or being secured to the main housingof the medicament administration device. The data collection device isconfigured to attach to and to effectively replace the part of themedicament administration device with which the user would normallyinteract. When a user wishes to dial a dose, they grasp and rotate thehousing 15 of the data collection device 14 which in turn rotates thedose setting dial 8. The user can continue to observe the mechanicaldose indication window 9 of the medicament administration device. Whenthe user wishes to inject a dose, they exert a force on the proximal endof the data collection device. This in turn communicates a force to thedose setting dial. The user would notice no material difference in theway in which they operate the medicament administration device as aresult of the addition of the data collection device according to thepresent invention.

The data collection device of the present disclosure may use infraredlight as an illumination source. This allows the external components ofthe medicament administration device to be made out of a plastic orother material which is opaque to optical wavelengths, but transparentor partially transparent to Infrared wavelengths. No additional cut out,aperture or the like are required, although only the appropriate areasof the medicament administration device may be made of the IRtransmissive material, effectively forming an Infrared ‘window’.

The relatively reflective and non-reflective regions of the pattern maybe printed, deposited, etched or otherwise created directly onto thenumber sleeve 10 or other suitable internal component during thatcomponent’s manufacture. In some examples, the internal component islocated in close proximity to the dose setting dial. The medicamentadministration device may then be assembled in the same way as before,using the same assembly method and tools. Therefore, only very minimalmodification of the medicament administration device design and creationis required in order to implement the invention.

As discussed above in relation to FIG. 6 , the light source 29 andoptical sensor 30 in FIG. 6 may instead be replaced with a magneticsensor. The relatively reflective and non-reflective regions of thepattern on the rotatable component 10 may be replaced by alternatingmagnetic regions and non-magnetic regions such that when the rotatablecomponent 10 is rotated during a dose dispensing operation, there is aperiodic change in the magnetic field detected by the magnetic sensor.

FIG. 7 is a block diagram of the data collection device 14. The datacollection device 14 includes a processor arrangement 28 including oneor more processors, such as a microprocessor, a Digital Signal Processor(DSP), Application Specific Integrated Circuit (ASIC), FieldProgrammable Gate Array (FPGA) or the like, together with memory units32 a, 32 b, including program memory 32 a and main memory 32 b, whichcan store software for execution by the processor arrangement 28. Thedata collection device includes the infrared light source 29 and theinfrared optical sensor 30. The processor arrangement 28 controlsoperation of the light source 29 and the optical sensor 30 and receivessignals from the optical sensor 30.

The data collection device 14 has a power source 27 which may be abattery, for example a coin cell. The data collection device 14 mayoptionally include a switch 33 configured to be triggered when orshortly before a dose is dispensed. To this end, the switch 33 mayinclude a pressure or touch sensitive area in the end plate 16 of thedata collection device 14, for example a piezoelectric switch. Theswitch 33 may control application of power from the power source 27 tothe processor arrangement 28 and other components of the data collectiondevice 14.

The switch may be a “wake-up” switch which, when operated, activates thedata collection device 14. The wake-up switch may be implementedoptically as an “optical wake-up sensor”. In particular, the underlyingrotatable component 10 may be white (or black). When the rotatablecomponent 10 is rotated, the relatively reflective and non-reflectiveregions of the rotatable component 10 move in front of the opticalwake-up sensor and the change in reflectance and/or colour can bedetected, providing the wake-up signal for the other electronics. Thischange in reflectance or colour can also be used to determine the startand end times of an injection process. In this case a switch asdescribed before may function to wake-up the electronics, including thelight source and optical sensor and an optical switch may use the changein reflectance or colour to determine start and end times of aninjection process. This could be helpful in determining if an injectionprocess has occurred or if a priming process has occurred. Further, thecolour/reflectance switch could be used to determine how long the buttonhas been pressed and use this to see if a dwell time has been respectedby the user.

A timer 34 is also included. The processor arrangement 28 may use thetimer 34 to monitor a length of time that has elapsed since an injectionwas completed, determined using the switch 33. Also optionally, theprocessor arrangement 28 may compare the elapsed time with apredetermined threshold, to determine whether a user may be attemptingto administer another injection too soon after a previous injection and,if so, generate an alert such as an audible signal and/or generate anoptical signal such as blinking one or more LEDs. The data collectiondevice 14 may comprise a number of LEDs or other light sources forproviding optical feedback to a user. For example, the LEDs may usedifferent colours and/or lighting patterns such as blinking withconstant or changing periodicity. On the other hand, if the elapsed timeis very short, it may indicate that the user is administering amedicament amount as a “split dose”, and the processor arrangement 28may store information indicating that a dosage was delivered in thatmanner. In such a scenario the elapsed time is compared with apredetermined threshold in the range of a few seconds, e.g. 10 secondsup to a few minutes, e.g. 5 minutes. According to an example thepredetermined threshold is set to 2 minutes. If the time elapsed sincethe last injection is two minutes or less, the processor arrangement 28stores information indicating that the dosage was delivered as a “splitdose”. Another optional purpose for monitoring the elapsed time by theprocessor arrangement 28 is to determine when the elapsed time haspassed a predetermined threshold, suggesting that the user might haveforgotten to administer another injection and, if so, generate an alert.

The processor is further configured to store data relating to date and/or time information, data relating to information from the opticalsensor 30, or combinations thereof. In particular, the memory isconfigured to store a combination of date and/or time information andinternal component rotation information retrieved from the opticalsensor 30 output data. In this way the memory is able to store a logthat provides a history of information on number sleeve 10 (or otherinternal component) rotation. Data can for example be stored in the mainmemory 32 a. Alternatively, data may be stored is a separate datastorage section (not shown) of the memory.

Since the number sleeve or other internal component rotates asmedicament is expelled from the injection device 1, the angle ofrotation measured by the optical sensor 30 is proportional to the amountof medicament expelled. It is not necessary to determine a zero level oran absolute amount of medicament contained in the injection device 1. Inthis way the sensor arrangement is less complex than compared to asensor arrangement that is configured for absolute position detection.Moreover, since it is not necessary to monitor the numbers or tick markson the number sleeve 10 displayed through the dosage window 9, the datacollection device 14 may be designed so that it does not obscure thedosage window 9.

An output 38 is provided, which may be a wireless communicationsinterface for communicating with another device via a wireless networksuch as wi-fi, Bluetooth®, or NFC, or an interface for a wiredcommunications link, such as a socket for receiving a Universal SeriesBus (USB), mini-USB or micro-USB connector. FIG. 8 depicts an example ofa system in which the data collection device 14 is connected to anotherdevice, such as a personal computer 39, via a wireless connection 40 fordata transfer. Alternatively or in addition, the data collection device14 may be connected to another device via a wired connection. Forexample, the processor arrangement 28 may store determined number sleeve10 rotation angles and time stamps (including date and/or time) for theinjections as they are administered by the user and subsequently,transfer that stored data to the computer 39. The computer 39 may beconfigured to calculate an administered dose based on furtherinformation entered by the user or a medical professional regarding thetype of injection device and the type of medicament.

The computer 39 maintains a treatment log and/or forwards treatmenthistory information to a remote location, for instance, for review by amedical professional.

According to some embodiments, the data collection device 14 may beconfigured to store data such as number sleeve 10 rotation angles andtime stamps of up to 35 injection events. According to a once-dailyinjection therapy this would be sufficient to store a treatment historyof about one month. Data storage is organized in a first-in first-outmanner ensuring that most recent injection events are always present inthe memory of the data collection device 14. Once transferred to acomputer 39 the injection event history in the data collection device 14will be deleted. Alternatively, the data remains in the data collectiondevice 14 and the oldest data is deleted automatically once new data isstored. This way the log in the data collection device is built up overtime during usage and will always comprise the most recent injectionevents. Alternatively, other configuration could comprise a storagecapacity of 70 (twice daily), 100 (three months) or any other suitablenumber of injection events depending on the therapy requirements and/orthe preferences of the user.

In another embodiment, the output 58 may be configured to transmitinformation using a wireless communications link and/or the processorarrangement 28 may be configured to transmit such information to thecomputer 39 periodically.

The specific embodiments described in detail above are intended merelyas examples of how the present invention may be implemented. Manyvariations in the configuration of the data collection device 14 and/orthe injection device 1 may be conceived.

In particular, while the embodiments above have been described inrelation to collecting data from an insulin injector pen, it is notedthat embodiments of the disclosure may be used for other purposes, suchas monitoring of injections of other medicaments. Although the datacollection device has been described primarily as comprising a singleinfrared light source 29, the data collection device may comprise aplurality of light sources 29. The plurality of light sources 29 may besupported at different positions on the electronics assembly 25 and maybe angled and or focused so as to illuminate a particular part of theinternal component 10 from a particular angle when the data collectiondevice is attached to the dose setting dial.

The data collection device 14 may optionally include a display (notshown), which could for example occupy the end plate 16 of the datacollection device 14. Various information can be displayed, such as thelength of time that has elapsed since an injection was completed, andwarning messages where a user is attempting to administer anotherinjection too soon after a previous injection.

1. A data collection device for releasable attachment to a rotatabledose setting dial of a medicament administration device, the datacollection device comprising: a first end; a second end opposing thefirst end; a cavity configured to receive the dose setting dial; and awall extending between a portion of a periphery of the first end and aportion of a periphery of the second end, wherein the first end, thesecond end and the wall together define the cavity and wherein the wallcomprises a slot located between the first end and the second end andconfigured to permit insertion of the rotatable dose setting dial of themedicament administration device through the slot and into the cavity.2. The data collection device of claim 1, wherein the data collectiondevice comprises an orientation element disposed within the cavity on aninner surface of the wall of the data collection device and wherein theorientation element is configured to prevent relative rotation of thedata collection device and the dose setting dial when the datacollection device is attached to the dose setting dial.
 3. The datacollection device of claim 3, wherein the orientation element is aprotrusion extending from the inner surface of the data collectiondevice.
 4. The data collection device of claim 1, wherein the datacollection device has a longitudinal axis and is configured to bemounted onto the rotatable dose setting dial by: orienting the datacollection device such that the longitudinal axis is parallel to an axisof rotation of the rotatable dose setting dial; and moving the datacollection device in a perpendicular direction with respect to the axisof rotation of the dose setting dial.
 5. The data collection device ofclaim 4, wherein the orientation element is aligned with an indentationon the rotatable dose setting dial when: the data collection device isoriented such that the longitudinal axis is parallel to an axis ofrotation of the rotatable dose setting dial; and the data collectiondevice is moved in a perpendicular direction with respect to the axis ofrotation of the dose setting dial and mounted onto the dose settingdial.
 6. The data collection device of claim 1, wherein when attached tothe rotatable dose setting dial of the medicament administration device,rotation of the data collection device causes rotation of the rotatabledose setting dial.
 7. The data collection device of claim 1, wherein thedata collection device comprises a coupling member disposed within thecavity on an inner surface of the first end and wherein the couplingmember is configured to engage with a channel of the dose setting dial.8. The data collection device of claim 7, wherein the coupling member isconfigured to couple the data collection device to the rotatable dosesetting dial when the rotatable dose setting dial is received in thecavity of the data collection device.
 9. The data collection device ofclaim 1, wherein when the data collection device is attached to the dosesetting dial, the first end of the data collection device is situated ata proximal end of the dose setting dial.
 10. The data collection deviceof claim 1, wherein when the data collection device is attached to thedose setting dial, a portion of the dose setting dial is visibleexternally of the data collection device when the data collection deviceis attached to the dose setting dial.
 11. The data collection device ofclaim 1, wherein the data collection device has a generally cylindricalshape.
 12. The data collection device of claim 1, wherein the datacollection device further comprises: a light source configured toilluminate a portion of a surface of a component of the medicamentadministration device including one or more relatively reflectiveregions formed on the surface of the component.
 13. The data collectiondevice of claim 12, wherein the data collection device comprises anoptical sensor configured to receive light reflected by at least therelatively reflective regions.
 14. The data collection device of claim12, wherein the data collection device further comprises a windowconfigured to allow light emitted by the light source to pass throughthe window.
 15. The data collection device of claim 1, wherein the datacollection device is configured to detect and measure rotation of a dialsleeve of the medicament administration device.
 16. The data collectiondevice of claim 1, wherein the data collection device comprises anon-contact magnetic sensor configured to detect magnetic regions on arotatable component of the medicament administration device.
 17. Asystem comprising: a medicament administration device comprising arotatable dose setting dial; and a data collection device for releasableattachment to the rotatable dose setting dial of the medicamentadministration device, the data collection device comprising: a firstend; a second end opposing the first end; a cavity configured to receivethe dose setting dial; and a wall extending between a portion of aperiphery of the first end and a portion of a periphery of the secondend, wherein the first end, the second end and the wall together definethe cavity and wherein the wall comprises a slot located between thefirst end and the second end and configured to permit insertion of therotatable dose setting dial of the medicament administration devicethrough the slot and into the cavity.
 18. A system as claimed in claim17, wherein the data collection device is attached to the rotatable dosesetting dial of the medicament administration device.
 19. A system asclaimed in claim 17, wherein the data collection device is configured tobe detached from the dose setting dial by moving the data collectiondevice in a perpendicular direction with respect to the axis of rotationof the dose setting dial and relative to the dose setting dial.
 20. Asystem as claimed in claim 17, wherein the when the dose setting dial isreceived in the cavity of the data collection device, an orientationelement of the data collection device is engaged with an indentation ofthe dose setting dial and a coupling member of the data collectiondevice is engaged with a channel of the dose setting dial.